Data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product

  • Email
  • Help
Current effective version

Reflection paper

Reference numberEMA/CHMP/SWP/620008/2012
KeywordsNano-sized colloidal intravenous iron preparation, similarity, reference medicinal product, pharmaceutical, non-clinical, clinical, characterisation, tissue bio-distribution
DescriptionThis document assists in the generation of relevant quality, non-clinical and pharmacokinetic clinical comparative data to support a marketing authorisation for an intravenous iron-based nano-colloidal product developed with reference to an innovator product.

Document history

First version

Current version

Reflection paper

Overview of comments

Draft reflection paper

Published: 27/03/2015

Published: 27/03/2015

Published: 16/09/2013

Superseded documentReflection paperPublished: 07/04/2011

Related content

How helpful is this page?

Average rating:

 Based on 33 ratings

Add your rating:

See all ratings
6 ratings
6 ratings
7 ratings
6 ratings
8 ratings

Tell us more